Ocera Therapeutics Announces Positive Results With AST-120 In Pouchitis

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 Oct 2007 - 0:00 PDT

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Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced that data from the first cohort of patients from an exploratory Phase 2 study evaluating the efficacy and safety of AST-120 in patients with active pouchitis was presented in a poster presentation at the American College of Gastroenterology Annual Scientific Meeting.

"A four-week treatment with AST-120 in patients with active pouchitis led to a significant decrease in symptoms of pouchitis and endoscopy scores in the first ten patients enrolled in the study," said Dr. Bo Shen, principal investigator at the Center for Inflammatory Bowel Disease, Cleveland Clinic. "These results were impressive with 44.4% of the patients achieving clinical remission and 55.6% achieving a clinical response."

"These promising results warrant the further evaluation of AST-120 for the treatment of pouchitis in controlled randomized studies," added Laurent Fischer, M.D. president and CEO of Ocera Therapeutics. "We are encouraged by these findings which further support our strategy of exploring AST-120 as a platform drug with the potential to address multiple gastrointestinal and liver diseases."

Patients who suffer from Ulcerative Colitis often require a resection of the colon to reduce the risk of cancer. A J-pouch is created to collect stools and the pouch often becomes inflamed, a condition known as pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. Pouchitis occurs in up to 40% of patients with a J-pouch and there are no treatments currently approved for this indication. An estimated 80,000 patients in the United States suffer from this condition, which qualifies as Orphan Drug. The current standard of care for pouchitis includes treatment with antibiotics such as ciprofloxacin and metronidazole and relapse is common.

In vitro adsorption studies have demonstrated that AST-120 has a high adsorption capacity for bile acids and bacterial toxins and is expected to protect the intestinal mucosa of the pouch from inflammation.

AST-120 was in-licensed from Kureha Corporation, Japan in 2005. Ocera announced last week that it completed enrollment in FHAST1, the Fistula Healing with AST-120 Phase 3 pivotal trial in Crohn's disease conducted in North America, Europe and Israel. Ocera also recently initiated proof-of-concept trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy.

About the Pouchitis Phase 2 Study

The proof-of-concept study conducted under investigator IND at Cleveland Clinic is evaluating 20 patients with active pouchitis treated with open label AST-120, 2 grams tid. The Primary efficacy endpoint is remission as defined by a Pouchitis Disease Activity Index (PDAI) less than 7 points which includes clinical, endoscopy and histology scores. Secondary endpoints include safety, clinical response measured by a decrease of PDAI of a least three points and Global Quality of Life score.

About Ocera Therapeutics, Inc.

Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the licensing, development and commercialization of proprietary compounds to treat a broad range of gastrointestinal and liver diseases. Ocera Therapeutics is based in San Diego and is pursuing the development of AST-120 in Crohn's disease and other gastrointestinal and liver diseases including Pouchitis, Hepatic Encephalopathy, Irritable Bowel Syndrome and Proton Pump Inhibitor-resistant Gastroesophageal Reflux Disease. Ocera Therapeutics has raised $26.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at http://www.oceratherapeutics.com.

For more information on Pouchitis and Inflammatory Bowel Diseases, visit the Crohn's and Colitis Foundation of America website as http://www.ccfa.org.

Ocera Therapeutics, Inc.
http://www.oceratherapeutics.com